Guidance for SARS-CoV-2 Point-of-Care Testing

Guidance for SARS-CoV-2 Point-of-Care Testing
Updated Nov. 24, 2020
Summary of Recent Changes

Revisions were made on November 13, 2020 to include:  

  • Added Frequently Asked Questions about Point-of-Care Testing

Point-of-care (POC) tests, such as some rapid tests for diagnosing an infectious disease, provide results within minutes of the test being administered, allowing for rapid decisions about patient care. POC tests can also extend testing to communities and populations that cannot readily access care. POC tests are used to diagnose COVID-19 in various settings, such as:

  • Physician offices
  • Urgent care facilities
  • Pharmacies
  • School health clinics
  • Long-term care facilities and nursing homes
  • Temporary locations, such as drive-through sites managed by local organizations

Summary: This CDC Web resource provides guidance on the regulatory requirements for SARS-CoV-2 POC testing, using POC tests safely, and information on reporting POC test results.

Regulatory Requirements for POC Testing

Who can do POC testing?

Sites that perform POC testing are required to have a Clinical Laboratory Improvement Amendments (CLIA) certificate; find information in this brochurepdf iconexternal icon. There are four different types of CLIA certificates, any one of which is appropriate for POC testing. See this Centers for Medicare & Medicaid Services (CMS) documentpdf iconexternal icon that describes the different types of CLIA certificates. A CLIA Certificate of Waiver is appropriate for POC testing and can be obtained as follows:

  1. Complete an application (Form CMS-116pdf iconexternal icon), available on the CMS CLIA websiteexternal icon or from a local State Agency.
  2. Send the completed application to the address of the local State Agencyexternal icon for the state where testing will be performed.
  3. Pay the CLIA Certificate of Waiver fee, following instructions provided by the State Agency.

See How to Obtain a CLIA Certificate of Waiverpdf iconexternal icon for more information. POC testing may be performed after the laboratory or testing site has received a CLIA certificate number.

The laboratory or testing site must keep its certificate information current. The State Agency should be notified of any changes to the laboratory or testing site ownership, name, address, or director within 30 days.

What tests can be used for POC?

See the US Food and Drug Administration (FDA) website for a list of the SARS-CoV-2 POC tests that have received Emergency Use Authorization (EUA)external icon. Tests that have been authorized for use in a POC setting will have a W, for Waived, in the Authorized Settings column of the FDA table. The laboratory or testing site must use a test authorized for POC use by FDA and must follow the manufacturer’s instructions for each POC test. The instructions for use provide specific information on how to perform the test, which specimens can be used, and the individuals who may be tested. All of the currently authorized tests are authorized for use on symptomatic individuals. However, CMS has indicatedpdf iconexternal icon that CLIA will temporarily allow CLIA laboratories and other CLIA testing sites to use SARS-CoV-2 POC antigen tests on asymptomatic individuals for the duration of the COVID-19 public health emergency.

For more information and additional resources for POC testing, see CDC’s Waived Tests Web page.

Expedited Review of CLIA Applications

On March 26, 2020, CMS issued a memorandumexternal icon for surveyors and laboratories, providing guidance that included expedited review of CLIA certificate applications during the COVID-19 public health emergency.

Temporary COVID-19 Testing Sites

During the COVID-19 public health emergency, the Centers for Medicare & Medicaid Servicesexternal icon (CMS) allows a laboratory or testing site to use its existing Certificate of Waiver to operate a temporary COVID-19 testing site in an off-site location, such as a nursing home or drive-through location. A temporary COVID-19 testing site can only perform waived COVID-19 tests and must be under the direction of the existing laboratory or testing site director.

Specimen Collection & Handling of Point-of-Care Tests

There are many different FDA-authorized SARS-CoV-2 tests for POC settings. Each has been authorized for use with certain specimen types. Each POC test should only be used with its authorized specimen type. Proper specimen collection and handling is critical for all COVID-19 testing, including those tests performed at POC settings. A specimen that is not collected or handled correctly may lead to inaccurate or unreliable test results. For additional general information about the proper collection of each of the specimen types, please refer to CDC’s Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19.

It is also important to use proper infection control practices when collecting and handling specimens for COVID-19 for POC testing. Whenever possible, after collecting the specimen, maintain at least six feet of separation from the person whose specimen was collected. CDC recommends using Standard Precautionspdf icon when collecting and handling specimens for POC testing. Standard Precautions include, but are not limited to, personal protective equipment (PPE), such as a laboratory coat, surgical mask or face shield, disposable gloves, and eye protection.

In addition, CDC recommends the following practices when performing POC tests:

  • Perform a risk assessment before testing to identify what could go wrong, such as breathing in infectious material or touching contaminated objects and surfaces. Then
  • Follow all of the manufacturer’s instructions for performing the test in the exact order specified.
  • Perform regular quality control and instrument calibration according to the manufacturer’s instructions. If quality control or calibration fails, identify and correct issues prior to proceeding with patient testing.
  • Do not reuse used test devices, reagent tubes, solutions, or swabs.
  • Discard tests and test components that have exceeded the expiration date or show signs of damage or discoloration (such as reagents showing any signs of alteration).
  • Change gloves between specimen collection and after adding specimens to the testing device.
  • Store reagents, specimens, kit contents, and test devices according to the manufacturer’s instructions, found in the package insert.
  • Reagents, test devices, and cassettes should not be opened until the test process is about to occur. Refer to the manufacturer’s instructions to see how long a reagent, test device, or cassette can be used after opening.
  • If the instrument allows for batch testing, develop a plan before testing begins to ensure that reagents, test device, cassette, and specimens are used within time periods specified by the test manufacturer.
  • If using an instrument to perform testing, decontaminate the instrument after each use; follow the manufacturer’s recommendations for using an approved disinfectant, including proper dilution, contact time, and safe handling.
  • Read and record results only within the amount of time specified in the manufacturer’s instructions. Do not record results from tests that have not been read within the manufacturer’s specified timeframe.
  • Handle laboratory waste from testing suspected or confirmed COVID-19 patient specimens as all other biohazardous waste in the laboratory. Currently, there is no evidence to suggest that laboratory waste needs additional packaging or disinfection procedures.

Laboratories and testing sites can find free, online training courses relevant to working with COVID-19 specimens on CDC’s Preparing and Supporting Laboratories Responding to COVID-19 Web page.

Reporting Requirements for Point-of-Care Testing

A CLIA-certified laboratory or testing site must report all COVID-19 diagnostic and screening test results to the individual who was tested or that individual’s healthcare provider. Depending on the test manufacturer’s instructions for use, which can be found at FDA’s EUA websiteexternal icon, the laboratory or testing site may be required to report a negative test result as a “presumptive negative.”

A CLIA-certified laboratory or testing site must also report all COVID-19 test results to their respective state, local,  tribal, or territorial health department in accordance with the Coronavirus Aid, Relief, and Economic Security (CARES) Act; refer to the CMS interim final rule for regulatory reporting requirementspdf iconexternal icon. In addition, laboratories and testing sites can find out more about How to Report COVID-19 Laboratory Data.

CMS-certified long-term care facilities are required by the Department of Health and Human Servicespdf iconexternal icon (HHS) to use the National Healthcare Safety Network (NHSN) to report SARS-CoV-2 point-of-care antigen test data, and other on-site COVID-19 laboratory testing data, to appropriate federal and state health authorities.

Frequently Asked Questions about POC Testing

Understanding and Using Standard Precautions

What are the recommendations for safe and appropriate specimen collection and handling for SARS-CoV-2?

Use Standard Precautions when handling specimens that will be tested for SARS-CoV-2. Specimens should be labeled with appropriate information to definitively connect each specimen to a patient. When transferring specimens from a collection area to a testing area, follow the instructions for the POC test used.

Standard Precautions include:

  • Performing hand hygiene
  • Cleaning and disinfecting environmental surfaces
  • Conducting risk assessments for the use of appropriate personal protective equipment (e.g., gloves, gowns, face masks or respirators, eye protection) based on activities being performed
  • Minimizing potential exposures (e.g., respiratory hygiene and cough etiquette)

 

Standard Precautions are the basic practices that apply to all patient care, regardless of the patient’s suspected or confirmed infectious state, and apply to all settings where care is delivered. These practices protect healthcare personnel and prevent healthcare personnel or the environment from transmitting infections to other patients.

Resources

Wearing Personal Protective Equipment (PPE)

How often should gloves be changed while collecting and processing specimens?

Use a new pair of gloves each time a specimen is collected from a different person. If specimens are tested in batches, also change gloves before putting a new specimen into a testing device. Doing so will help to avoid cross-contamination.

Disinfecting Work Surfaces

What disinfectant should be used to disinfect work surfaces?

Use an Environmental Protection Agency (EPA)-registered disinfectant from List N: Disinfectants for Coronavirus (COVID-19)external icon. Follow the manufacturer’s recommendations for use, such as dilution, contact time, and safe handling.

For general instructions about using EPA-registered disinfectants, refer to EPA’s 6 Steps for Safe & Effective Disinfectant Usepdf iconexternal icon.

One of the most commonly available disinfectants is bleach. Use bleach containing 5.25%–8.25% sodium hypochlorite and prepare a 1:10 diluted bleach solution. Follow the manufacturer’s application instructions for the surface, ensuring a contact time of at least 1 minute.

For more general instructions about using diluted bleach solutions, refer to the resources below.

Resources

How should a 1:10 diluted bleach solution be prepared to disinfect surfaces?

  1. Check the label to ensure the bleach contains 5.25%-8.25% sodium hypochlorite. If there is no label or the bleach is past the expiration date, don’t use it.
  2. For every 9 portions of water, add 1 portion of bleach.
  3. Keep the solution in a closed container when not in use.
  4. Label the container with the time and date the solution was made.
  5. After 24 hours, discard the remaining diluted bleach solution and make a new batch.
  6. Never mix household bleach with ammonia or any other cleaner because fumes may be hazardous to inhale.

How should work areas and surfaces be disinfected before and after testing?

  • Always wear gloves appropriate for the chemicals being used when you are cleaning and disinfecting. Additional personal protective equipment (PPE) may be needed based on setting and product. For more information, see CDC’s website on Cleaning and Disinfection for Community Facilities.
  • Disinfect surfaces where specimen collection, handling, and testing occur. Examples include tables, chairs, and bed frames.
  • Use an Environmental Protection Agency (EPA)-registered disinfectantexternal icon when disinfecting surfaces where specimens are collected and processed. Follow the manufacturer’s application instructions for use, such as dilution, contact time, and safe handling.
  • Ensure proper ventilation during and after application, so no one inhales fumes from the disinfectant.

It is important to follow these recommendations to avoid cross-contamination and keep workers safe.

Resources

 

Resource

Detailed Disinfection Guidance

When should surfaces near a specimen collection and handling site be disinfected?

Disinfect surfaces within 6 feet of the specimen collection and handling area at these times:

  • Between each specimen collection
  • In the event of a specimen spill or splash
  • When visibly soiled
  • At least hourly during testing
  • Before testing begins each day
  • At the end of every testing day

Resource

Performing Facility-wide SARS-CoV-2 Testing in Nursing Homes

More Point-of-Care Resources